Drug product
fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
D-1008-2017
Product summary
- Event
- Event 77770
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1008-2017
Official wording
Reason: Lack of Assurance of Sterility; product has the potential to leak.
Code information: Lots: 20170428@57 BUD: 7/27/2017; 20170428@58 BUD: 7/27/2017; 20170511@24 BUD: 8/9/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility